Randomization & Trial Supply Management

Innovative Randomization and Trial Supply Management System (RTSM)

THE ONLY BIOSTATISTICS-DRIVEN RTSM

Sponsors use ID-net™ to monitor patient recruitment in real time, while investigators use the same Internet platform to allocate treatments to patients in clinical trials.

Based on the latest IT technology, and seamlessly integrated with our EDC system, ID-net™ the IDDI Randomization and Trial Supply Management System (RTSM) platform is highly configurable, allowing a fast set-up of critical features such as randomization, treatment allocation and trial supply inventory.

Our biostatisticians work hand-in hand with the RTSM team to provide the most appropriate randomization methodology.

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KEY BENEFITS OF ID-net – IDDI RANDOMIZATION & TRIAL SUPPLY MANAGEMENT (RTSM)

FAST DELIVERY

  • Timelines ranging from 4 to 8 weeks
  • Randomization without Trial Supply: 4 weeks
  • Randomization with trial supply: 8 weeks

CONFIGURABLE SYSTEM

  • Fast implementation of protocol amendments.
  • Adjustable throughout the study with no downtime
  • Provides real-time information to Sponsors, Monitors, Investigators and all trial participants

BIOSTATISTICS DRIVEN RTSM

  • In-house biostatisticians & Randomization Teams to provide the most appropriate randomization methodology & follow-up
    • Stratified randomization using dynamic or static schemes
    • Minimization,
    • Permuted block,
    • Multi-stage,
    • Adaptive designs

SUPPORTS ALL TYPES OF RANDOMIZATION SCHEMES

  • Fixed, dynamic, multi-stage, adaptive

INTEGRATED WITH EDC

  • Real-time integration with IDDI EDC system (ID-base)
  • Direct integration with various EDC and drug supply distributors.
  • Easily plugged into any EDC.

EASY SET UP INTERFACE

  • User-friendly interface on all browsers
  • Compatible with tablets and Smartphones
  • 21 CFR Part 11 Validated system

COMPLEX TRIAL SUPPLY ALGORITHMS

  • Various trial supply strategies per site
  • Scheduling of patient visits, single sign-on to access multiple studies, different profiles per user and per study.
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128
Randomization systems implemented
71
countries (all continents)
29317
patients


KEY FEATURES OF ID-net IDDI RTSM

REGISTRATION

  • Eligibility checks, patient number, screen failure tracking.

RANDOMIZATION

  • Stratified randomization using dynamic or static schemes.
  • Randomization methods: Minimization. Permuted block. Multi-stage randomization designs. Response adaptive designs. Adaptive dose-findings.
  • Email confirmation.

TREATMENT ALLOCATION

  • Blinded treatment allocations.
  • Open treatment allocations.
  • Dose and treatment variations.
  • Emergency code breaks.
  • Real time online reports for sponsor, monitors and site users.
  • Scheduling of subjects and monitoring visits.
  • Adaptive automatic drug supply process

HELPDESK

  • 24/7 helpdesk by IDDI employees

TRIAL SUPPLY MANAGEMENT

  • Reduce wastage and costs
  • Automatic trial supply management based on subject accrual and treatment
  • Management of product life cycle (shipments, allocation, quarantine, tracking of damage…)
  • Relabeling and management of expiry date
  • Advanced inventory reports
  • Trial supply tracking and inventory.

HELP FROM QUALIFIED STAFF

  • Attendance to investigators meeting in person or web training.
  • Study specific user manual provided to monitors and participating sites.

SECURITY

  • Secured access only to authorized users.
  • TLS and data encryption from the server.
  • Secure servers and mirrored systems with on-site and off-site backup
  • Full audit trail.
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